Vial Label: 1) LIATEST VWF:Ag Buffer — Class II medical device recall Z-0951-2013
Terminated recall by Diagnostica Stago, Inc., reported 2013-03-20. Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered perce
| Recall number | Z-0951-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2013-01-28 |
| Classified | 2013-03-14 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-07-19 |
| Countries outside the US | CA |
| Quantity | 2,901 kits |
| Lot numbers | 108128, 108512, 108778, 109415, 109591, 2013-03, 2013-04, 2013-07, 2013-10, 2014-01 |
| Model numbers | 00518, 58978, 58979 |
Product
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asni¿res sur Seine (France) Coagulation Assay
Reason for recall
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0951-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.